Explore the IVD requirements currently available for Brazil, organized by topic and linked to official sources.
Common questions about changing a registered IVD in Brazil. Each question separates published rules from details still awaiting verification.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
An immediate alteration that is interdependent with an approval-required alteration must be filed jointly with it and incorporated into that petition. Approval-required changes take effect only after the final decision is published in the Diário Oficial da União.
Transfer requires the signed petition form, GRU proof of TFVS payment/exemption, Annex I transaction declaration and updated operating/sanitary licence. Pending initial applications are updated by an amendment rather than a transfer of an issued registration. Pending post-registration petitions transfer only when declared in Annex I; unlisted petitions are closed. Holder-only label/IFU updates may be implemented after transfer approval.
For an unchanged registered product, the successor’s holder-transfer petition and predecessor’s cancellation petition must be filed concurrently within 180 days of the registered corporate act or asset-transfer contract, subject to the separate Mercosur trigger. Late petitions are refused. Products subject to notification or exemption are not transferred: the successor makes a new notification or regularization. A simple same-person corporate-name change is excluded from this transaction regime.
Registered IVD commercial-name change subject 8007 requires updated primary/secondary label images, updated IFU/manual, a digitally signed technical-responsible declaration listing the changes, and affected portions of the technical dossier.
IVD transfer subject 80074 (product) and80078 (family) require the RDC 903 Annex I declaration digitally signed by legal and technical responsibles, the updated operating/sanitary licence and an Anvisa GMP certificate in the successor’s name or its application protocol. Parent RDC 903 Art. 30 also requires the petition form and TFVS payment/exemption. The family subject is not proof that an arbitrary collection of products qualifies as a family.
Subject8011 requires updated labels and IFU, a technical-responsible signed change declaration identifying the manufacturer, the apostilled/consularized imported-manufacturer authorization and GMP undertaking, and affected dossier sections. Multiple legal manufacturers need same-group proof. If the legal manufacturer is itself the factory, include the updated Anvisa GMP certificate or protocol and also file the approval-required manufacturing-site alteration.
For subject 80198, submit primary/secondary labels and an updated IFU highlighting changes, or justified no-impact documents, plus the technical-responsible signed change declaration. Affected technical-dossier portions are required by this list for class II. A change of notification holder is governed separately by the new-notification rule.
Subject8020 is exclusively a foreign legal-manufacturer or manufacturing-unit corporate-name change. Supply label/IFU updates or justified no-impact statements, the manufacturer’s reason document, the imported legal-manufacturer authorization where its name changes, the updated Anvisa GMP certificate or protocol where the plant name changes, and affected dossier sections. Address/process changes use their pertinent subjects; corporate purchase, sale, merger or division is a manufacturer/site change, not this name-only subject.
IN 74 Annex II lists commercial-name changes and foreign legal-manufacturer or factory corporate-name changes as immediate subjects. For equipment and materials it also expressly lists commercial-model name/code changes. The IVD rows separately list commercial name, commercial presentation and legal manufacturer without a manufacturing-process change; the equipment model/code wording must not be applied automatically to an IVD orderable REF.
File the applicable petition subject, the fee or exemption where applicable, a declaration listing the requested alterations, and documentary evidence supporting them. A single label mock-up does not replace the subject-specific technical dossier or manufacturer evidence.
Changes to notification or registration are approval-required, immediate, or non-reportable. Classes I/II use immediate implementation except non-reportable changes. Minor non-technical images, layout, symbols or text without added risk, and contact/postal-address updates, can be non-reportable when they do not change the design; control them in the holder’s quality system and incorporate them into later petitions. A trade-name change is not automatically a logo-artwork exemption.
The official registered-device alteration FAQ says that a petition permits only its requested alteration item and other inserted alterations are disregarded. This must be read with the legal rule requiring an interdependent immediate change to accompany the approval-required change. It does not authorize combining every name/address/REF/holder change into one fee or decision.
RDC 903 Arts. 7–14 require the applicable company-authorization and GMP/distribution-certificate updates following corporate/commercial operations. A new legal person or unregularized successor needs initial AFE/AE as applicable. For a qualifying unchanged production line, CBPF update preserves certificate validity; an exclusively foreign operation is petitioned by the current certification applicant. Art. 13 lists the form, existing certificate, transaction declaration, applicable updated AFE publication, and successor-country GMP certificate or competent-authority transaction attestation for a foreign operation.
What local class follows from which rules and decisive product facts?
registration
What regulator fee applies to this class, route, event, and date?
RDC 857 Annex I7.9.1 sets product-registration alteration/inclusion factor 738 DV2 at BRL3514.32,2987.17,2460.02,1405.73,351.43 or175.72 by company-size column. The separate label/IFU alteration item7.9.2 factor 742 DV0 is exempt. Map the actual petition subject to its factor; a commercial-name or manufacturer change is not automatically a label-only exempt petition.
RDC 857 Art. 10 conditions holder transfer on any positive TFVS difference associated with the successor’s economic size and provides no refund if it is smaller. Simultaneous renewal and later transfer use the specified size-reference dates; a later transfer also triggers the alteration charge. Calculate the actual petition and size difference rather than assuming an ordinary label-only exemption.
Which label and IFU elements, languages, symbols, and translation controls apply?
The successor is responsible for remaining finished stock. Finished stock produced before the individual transfer/cancellation resolutions take effect may be imported or sold for at most180 days after that effective date. Outdated packaging cannot be used for new lots produced afterwards. Unless otherwise stated, those individual resolutions take effect90 days after publication. These180/90-day periods are stock/effect rules, not agency review periods.
For an ordinary alteration, old and new finished-device versions may be imported and sold until expiry or the end of useful life. Unused packaging, labels and IFUs may be exhausted for 120 days from publication of the alteration. Changes made to resolve safety or performance problems are excluded from both permissions. The publication trigger does not create an implementation-date clock for an unpublished non-reportable artwork change.
Which current form, portal, account, and submission package must be used?
RDC 830 Arts. 13–14 require the imported-IVD legal-manufacturer authorization naming the full manufacturer and applicant names/addresses, representation/commercialization rights and GMP undertaking; use apostille/consularization and Portuguese, English, Spanish or sworn translation, within two years if validity is unstated. Art. 14 does not list a blanket CFS item. Subjects8011/8020 require the specific updated authorization; this is not a general CFS-reissue duty.
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
Prior approval / evidence record
A device that has no Armenian state registration can still be imported, but the import (conformity) certificate file must contain a document confirming that the device is authorised for use — state registration or free circulation — in its country of manufacture or in an IMDRF member country, or a reasoned reference to such a document, including a Declaration of Conformity with references to the relevant registers. This is the origin-country free-sale certificate requirement: a Turkish, Korean, Chinese or European exporter must produce its home-country registration/free-sale evidence (or an IMDRF-country equivalent) even though the device is not registered in Armenia. The document is mandatory paperwork; the Armenian expert organisation still examines the file and the Ministry of Health still decides.
Registration / free circulation in the country of manufacture, or in any IMDRF member country — US FDA, EU member states (CE), Japan PMDA, Korea MFDS, China NMPA, Canada, Australia, Brazil, Singapore, UK — evidenced by a registration certificate, free-sale certificate or a Declaration of Conformity with register references
Origin Country Evidence
Evidence Only
Import Control
Yes
Yes
Language: Armenian. Verbatim, Government Decree No. 429-Ն of 30.03.2023, Annex No. 2, para. 2(2)(a): "պետական գրանցում չունեցող բժշկական արտադրատեսակների համար՝ ա. բժշկական արտադրատեսակի արտադրող երկրում կամ Բժշկական արտադրատեսակների կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրներում կիրառման թույլտվությունը (պետական գրանցումը, ազատ կիրառումը) հավաստող փաստաթուղթ կամ դրա վերաբերյալ փաստարկված տեղեկանք, այդ թվում՝ բժշկական արտադրատեսակների համապատասխանության հայտարարագիր (Declaration of Conformity) համապատասխան գրանցամատյանների հղումով". Translation: "for medical devices without state registration: a. a document confirming authorisation for use (state registration, free circulation) in the country of manufacture of the medical device or in member countries of the International Medical Device Regulators Forum (IMDRF), or a reasoned reference thereto, including a Declaration of Conformity for the medical device with reference to the relevant registers".
Prior approval / evidence record
Armenia registers medical devices under two national procedures: a general procedure and a simplified procedure. The simplified procedure applies to a device that is registered in a country that is a member of the International Medical Device Regulators Forum (IMDRF) or that is prequalified by the World Health Organization. IMDRF members include the United States (FDA), the EU member states (CE marking), Japan (PMDA), Korea (MFDS), China (NMPA), Canada, Australia, Brazil, Singapore and the United Kingdom, so a US FDA 510(k)/PMA clearance, an EU CE mark, a Japan PMDA approval and a Korea MFDS approval all satisfy the gate. The device is still registered in Armenia by the Armenian authority — the foreign registration opens the shortened procedure, it does not replace the Armenian certificate.
Registration in any IMDRF member country — US FDA 510(k)/PMA, EU CE marking under MDR/IVDR (any EU member state), Japan PMDA, Korea MFDS, China NMPA, Health Canada, Australia TGA, Brazil ANVISA, Singapore HSA, UK MHRA — or WHO prequalification of the device
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Language: Armenian. Verbatim, Article 46(4): "Սույն հոդվածի 3-րդ մասով սահմանված կարգի համաձայն՝ բժշկական արտադրատեսակները գրանցվում են ընդհանուր և պարզեցված ընթացակարգերով: Պարզեցված ընթացակարգը կիրառվում է բժշկական արտադրատեսակների շրջանառությունը կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրում գրանցված կամ Առողջապահության համաշխարհային կազմակերպության նախաորակավորած բժշկական արտադրատեսակների համար:" Translation: "Under the procedure laid down by part 3 of this article, medical devices are registered under general and simplified procedures. The simplified procedure applies to medical devices registered in a member country of the International Medical Device Regulators Forum (IMDRF) or prequalified by the World Health Organization." Article 46 was amended by the Law of 5 December 2024 ՀՕ-502-Ն; the consolidated expression is the version in force from 31.05.2026.
Prior approval / evidence record
ANVISA (Brazil)
No
Brazil is not on the INVIMA reference-country list and there is no device mutual recognition agreement in force
None
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
PAHO/PARF regional reference authorities (ARNr) — ANMAT, ANVISA, CECMED, INVIMA, COFEPRIS
Yes
Same simplified-procedure eligibility as the WHO Strict Authorities under Resolución No. 000004.
No published period.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Health Canada, Japan MHLW/PMDA, UK MHRA, Brazil ANVISA and Australia TGA approvals
Yes
Also recognised reference authorities under the Abridged Review Pathway, on the same terms as the FDA and EU routes: identical product required, national requirements still assessed, final acceptance decided by the Administration.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
GHTF/IMDRF member countries — free-sale certificate (شهادة بيع حر)
Yes
A mandatory document rather than a route: Decision 1506/1 Art. Four requires the registration application to carry a free-sale certificate issued by a country belonging to the GHTF/IMDRF group, meaning the device is sold in one of those countries whatever its origin, and the Ministry's service records require a free-sale certificate with an ISO 13485 certificate where the goods are made outside the reference states or the listed documents cannot be produced. No examination period is shortened by it.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)
The single reliance route since the DOF Acuerdo of 18 July 2025, which took effect 30 working days after publication and abrogated every individual equivalence agreement issued between 2012 and June 2025 — the separate FDA, Swissmedic, European Commission, Health Canada, TGA and WHO prequalification acuerdos no longer exist. COFEPRIS now recognises the decision of any Reference Regulatory Authority from a country sitting on the IMDRF Management Committee, and MDSAP full membership for GMP certificates. The dossier drops to an administrative-legal section plus technical information under RIS Art. 31.
Resolution within a maximum of 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-ii
Class II
medium
Registration or Equivalency
35
35
days
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
15
31
months
8
16
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-iii
Class III
highest
Registration or Equivalency
60
60
days
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
15
31
months
8
16
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
For IVDs, DINAVISA decides within 30 business days for products manufactured nationally or in a country of Annex I, within 45 business days for products manufactured outside Annex I but registered and commercialised in an Annex I country (which must additionally file the foreign registration certificate and free-sale certificate), and within 120 business days for other imports. Annex I names high-surveillance and adequate-surveillance authorities and the full MERCOSUR members; the United States and Japan are on it and Korea is not.
Sanitary registration and free-sale certificate in force in an Annex I country — high-surveillance authorities (Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden, Switzerland) or adequate-surveillance authorities (Australia, Chile, Cuba, Finland, Hungary, Ireland, Luxembourg, Mexico, Norway, New Zealand); Annex I also lists full MERCOSUR members (Argentina, Brazil, Paraguay, Uruguay) and PAHO/WHO reference authorities
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Source language: Spanish. Translation of the quoted Annex I heading and entries: 'Countries with High and Adequate Sanitary Surveillance Authorities (Law 3283/07 Article 11)' / 'Countries with high sanitary surveillance regulatory authorities: Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden and Switzerland.' / 'Full MERCOSUR members: Argentina, Brazil, Paraguay and Uruguay.' The excerpt is taken from the resolution's own Annex I; Art. 6 supplies the 30- and 45-business-day clocks.
Prior approval / evidence record
PAHO/WHO reference authority or IMDRF Management Committee member authority
Yes
Operative for class II, III and IV IVDs, which enter the Proceso Simplificado de Registro Sanitario under Resolución DINAVISA N° 44/2024 with a 15-business-day validation and approval by positive silence.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Class II, III and IV in-vitro diagnostic products already authorised and commercialised in countries regulated by PAHO/WHO reference regulatory authorities, by authorities of IMDRF Management Committee member countries, or by authorities with bilateral agreements with DINAVISA enter the Proceso Simplificado de Registro Sanitario (PSR). DINAVISA has 15 business days to validate and decide, and approval follows by positive silence if no report is issued.
PAHO/WHO reference regulatory authorities; authorities of IMDRF Management Committee member countries (the IMDRF committee includes US FDA, EU, Japan PMDA/MHLW, Health Canada, TGA, ANVISA, China NMPA, Korea MFDS, Singapore HSA and UK MHRA); authorities with bilateral agreements with DINAVISA
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2024-01-30
Source language: Spanish. Translation of the operative part of Art. 2: 'Applications for sanitary registration of In Vitro Diagnostic Products ... that are authorised and commercialised in countries regulated by: PAHO/WHO Reference Regulatory Authorities; Regulatory Authorities of member countries of the Committee of the International Medical Device Regulators Forum - IMDRF; Regulatory Authorities with which bilateral agreements with DINAVISA exist, shall be subject to the Simplified Sanitary Registration Process (PSR).' and 'DINAVISA shall have a term of 15 (fifteen) business days to validate the required documentation and decide thereon. Once the term has elapsed with no report from DINAVISA, the application shall be approved.' Article numbering confirmed by reading the page image of the official PDF.
Prior approval / evidence record
Proceso simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro
Class II, III and IV IVDs (Res. 44/2024 Art. 7) already authorised and commercialised by a recognised reference authority are validated in 15 business days with approval by positive silence, instead of the 30, 45 or 120 business days of the ordinary IVD route.
From 30-120 business days down to 15 business days
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
class-iii
Class III
high
Registration
66
66
working-days
official-verified
DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
2026-08-25
6
12
months
4
7
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-ii
Class II
medium
Registration
44
44
working-days
official-verified
DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
2026-08-25
4
8
months
3
5
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
ANVISA (Brazil)
No
Brazil is neither a high-surveillance country under art. 9 nor a member of the Andean Community, so neither the documentary route nor CAN harmonisation applies to a Brazilian registration.
None
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
WHO Prequalification, or quality-system certification from a certification body accredited by a regulatory authority in an IMDRF founding-member country, or any other international organisation recognised by NDA
Yes
Track 2: accepted as a documentary substitution for an IMDRF-country licence under DAR/GDL/028 §4.12.2 — the foreign element that unlocks the route is the quality-system certification and its accreditation rather than a product approval, and no shortened period is published for it.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Licence or approval from an IMDRF founding-member country — Australia, Canada, the European Union, Japan, the United States
Yes
Track 1: an abridged evaluation in which the foreign approval carries the technical assessment, with a much smaller submission (attestation, abbreviated product and manufacturer details, notarized copy of the licence, Certificate of Analysis to an accepted quality-system standard, evidence of repeat sales and product samples where practicable). It is an expedited review with shortened registration timelines, but NDA publishes no number for the shortening and the final decision remains NDA's.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
WHO Prequalification; US FDA approval; EU CE marking; approval in any IMDRF member state
No
Disclosure only. The Annex I application form requires the applicant to state whether the device is WHO prequalified, US FDA approved, CE marked or approved in any IMDRF member state and to attach valid documentation, but neither the non-IVD nor the IVD guideline attaches any procedural consequence — no shortened clock, no abridged dossier and no substitute for ZAMRA's own evaluation.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
EU CE Mark
No
Not an AREE under IN 290/2024 Art. 6
None
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Japan MHLW
Yes
Recognised AREE for IN 290/2024, evidenced by the Shonin pre-market approval
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Health Canada
Yes
Recognised AREE for IN 290/2024, evidenced by the Medical Device Licence
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-iv
Class IV
highest
Registration
250
320
days
official-verified
ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
2026-08-25
1
11
months
10
14
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
ANVISA's optimized (reliance) review for Class III/IV device registration under RDC 741/2022 is available only for devices previously authorized by an AREE listed exhaustively in IN 290/2024 Art. 6: TGA (ARTG), Health Canada (Medical Device Licence), US FDA (510(k)/PMA/De Novo) and Japan MHLW (Shonin). China's NMPA is not listed, so an NMPA registration certificate gives no access to the optimized procedure and the ordinary route (RDC 751/2022 / RDC 830/2023) applies.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
brazil
NMPA Class II/III certificates and Class I filings; target: ANVISA Class III/IV registration (optimized procedure)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2024-06-03
Source passage: Art. 6º Para fins de adoção do procedimento otimizado de análise são consideradas as seguintes AREE e respectivas comprovações de registro ou autorização: I - Austrália: Australia Therapeutic Goods Administration (TGA) - Australian Register of Therapeutic Goods (ARTG); II - Canadá: Health Canada (HC) - Medical Device Licence; III - Estados Unidos da América (EUA): US Food and Drug Administration (US FDA) - 510(k) Clearance, Premarket Approval (PMA) ou 513(f)(2) "De Novo"; e IV - Japão: Japan Ministry of Health, Labour and Welfare (MHLW) - Pre-market approval (Shonin).
Prior approval / evidence record
class-iii
Class III
high
Registration
250
320
days
official-verified
ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
2026-08-25
1
11
months
8
12
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
MDSAP B-GMP validity extension (RDC 850/2024)
RDC 497/2021 Art. 8 gives a Brazilian GMP certificate two years. RDC 850/2024 added a first paragraph doubling that to four years where the certificate was granted through MDSAP, conditional on the manufacturer staying in MDSAP for the whole certificate period.
4 years of B-GMP validity instead of 2, so one renewal cycle removed
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
NMPA Commissioner Jiao Hong and ANVISA Director-President Antonio Barra Torres signed a Memorandum of Understanding on cooperation on 26 November 2020 covering information exchange in the regulation of drugs, medical devices and cosmetics. ANVISA's official cooperation page lists the 'Memorando de Entendimento entre Anvisa e NMPA' under China, and a separate BRICS regulators' MoU. Neither instrument creates recognition of NMPA registrations; they are information-exchange frameworks.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
brazil
All device classes (framework MoU; no product-level effect)
Cooperation Mou
none
Product Marketing
Yes
Yes
Effective from 2020-11-26
Source passage: The National Medical Products Administration (NMPA) Commissioner Jiao Hong signed a memorandum of understanding (MoU) on cooperation with Antonio Barra Torres, head of the Brazilian health regulatory agency ... on Nov 26. ... have agreed to further strengthen information exchanges in regulation of drugs, medical devices and cosmetics under the framework of the MoU
Prior approval / evidence record
MDSAP
Yes
Audit reports substitute for the inspection report at B-GMP certification and extend the certificate to 4 years, but RDC 687/2022 Art. 14 keeps ANVISA free to inspect on site at any time, including during the certificate validity
Removes the wait for an ANVISA inspection slot
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
FDA 510(k)/PMA/De Novo
Yes
Recognised AREE for IN 290/2024 optimized analysis of Class III and IV registrations
None published — Art. 10 preserves queue position
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Optimized analysis (procedimento otimizado, IN 290/2024)
ANVISA uses the analysis already performed by a recognised equivalent foreign regulator as the sole or complementary reference for the registration decision. It shortens how much ANVISA has to re-review, not where the petition sits in the queue: Art. 10 states expressly that adopting the optimized procedure does not change the chronological order of petitions, and ANVISA publishes no reduced deadline for it.
No published reduction — the RDC 743/2022 deadlines still apply and Art. 10 preserves queue position
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
TGA (Australia)
Yes
Recognised AREE for IN 290/2024, evidenced by the ARTG entry
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
What review, validation, and applicant stop-clock rules apply?
Under Decree 10178 Arts. 10–15, the approval period starts when all necessary instruction elements are submitted; the authority must state the deadline. A documentary-complement request can suspend the clock, with the stated new-fact exception. These provisions do not create a universal 60-day or 90-day device alteration period.
RDC 743’s Annex lists 30 days for the enumerated immediate device/IVD alteration subjects and 150 days for approval-required subjects; the latter rows exclude tacit approval. These are printed as days, not expressly working days. MD Art. 22 as replaced by RDC 777, and IVD RDC 830 Art. 22, provide publication independently of documentary review without printing the old 30-day publication phrase. Do not treat the table as a guaranteed pre-implementation wait or as approval for any combined transfer.
Which UDI, device listing, database, and traceability duties apply?
RDC 591 Annex II2.9 as amended by RDC 884 requires a new UDI-DI where a change could create identification ambiguity, and expressly for trade/commercial-model name changes. Under2.12 a label change solely to add UDI is not itself a regularization-change petition. A customer’s internal REF is not automatically a commercial model or UDI-DI; establish what registered and issued identifiers actually change.
IN 426 Art. 8 requires completion of the formal RDC 903 holder transfer before SIUD data transfer; successor data are transmitted for the new registration numbers within 30 days after the individual transfer/cancellation resolutions take effect. Art. 7§3 separately gives30 calendar days from publication for replacement where the change requires a new UDI-DI. These data deadlines are not agency variation-review periods.
brazil:medical-device
brazil
Risk classes I through IV for general devices and IVDs.
i
Class I
low
ii
Class II
medium
iii
Class III
high
iv
Class IV
highest
ANVISA
official-source-verified
ANVISA RDC 751/2022 English translation
https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf
2026-08-13
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
Brazil
brazil
BR
🇧🇷
Agência Nacional de Vigilância Sanitária
ANVISA
americas
1
4-class (I, II, III, IV)
class-i
Class I
low
Notification
30
30
days
official-verified
ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
2026-08-25
1
1.5
months
No
No
No
class-ii
Class II
medium
Notification
30
30
days
official-verified
ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
2026-08-25
1
1.5
months
No
No
No
class-iii
Class III
high
Registration
250
320
days
official-verified
ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
2026-08-25
1
11
months
8
12
months
No
No
Yes
class-iv
Class IV
highest
Registration
250
320
days
official-verified
ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
2026-08-25
1
11
months
10
14
months
Yes
No
Yes
Optimized analysis (procedimento otimizado, IN 290/2024)
ANVISA uses the analysis already performed by a recognised equivalent foreign regulator as the sole or complementary reference for the registration decision. It shortens how much ANVISA has to re-review, not where the petition sits in the queue: Art. 10 states expressly that adopting the optimized procedure does not change the chronological order of petitions, and ANVISA publishes no reduced deadline for it.
No published reduction — the RDC 743/2022 deadlines still apply and Art. 10 preserves queue position
MDSAP B-GMP validity extension (RDC 850/2024)
RDC 497/2021 Art. 8 gives a Brazilian GMP certificate two years. RDC 850/2024 added a first paragraph doubling that to four years where the certificate was granted through MDSAP, conditional on the manufacturer staying in MDSAP for the whole certificate period.
4 years of B-GMP validity instead of 2, so one renewal cycle removed
FDA 510(k)/PMA/De Novo
Yes
Recognised AREE for IN 290/2024 optimized analysis of Class III and IV registrations
None published — Art. 10 preserves queue position
EU CE Mark
No
Not an AREE under IN 290/2024 Art. 6
None
MDSAP
Yes
Audit reports substitute for the inspection report at B-GMP certification and extend the certificate to 4 years, but RDC 687/2022 Art. 14 keeps ANVISA free to inspect on site at any time, including during the certificate validity
Removes the wait for an ANVISA inspection slot
TGA (Australia)
Yes
Recognised AREE for IN 290/2024, evidenced by the ARTG entry
None published
Health Canada
Yes
Recognised AREE for IN 290/2024, evidenced by the Medical Device Licence
None published
Japan MHLW
Yes
Recognised AREE for IN 290/2024, evidenced by the Shonin pre-market approval
None published
Yes
Brazil Registration Holder (BRH)
Yes
MDSAP audit reports stand in for the inspection report when ANVISA grants or renews the B-GMP certificate, and RDC 850/2024 extends that certificate to 4 years for as long as the manufacturer stays in the programme. It is not an inspection waiver: RDC 687/2022 Art. 14 lets ANVISA inspect on site at any time, and refusing an inspection cancels the certificate.
Unlimited (Class I-II), 10 years (Class III-IV)
official-verified
ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
2026-08-25
ANVISA IN 290/2024 — optimized analysis of Class III and IV device registration petitions using an equivalent foreign regulator (AREE)
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=INM&numeroAto=00000290&seqAto=000&valorAno=2024&orgao=DC/ANVISA/MS&cod_menu=1696&cod_modulo=134
2024-06-03
2026-08-30
ANVISA RDC 687/2022 — criteria for granting and renewing the Brazilian GMP certificate for medical devices
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000687&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_menu=1696&cod_modulo=134
2022-06-01
2026-08-30
ANVISA RDC 850/2024 — amends RDC 497/2021 Art. 8 to give MDSAP-based device GMP certificates four years of validity
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000850&seqAto=000&valorAno=2024&orgao=RDC/DC/ANVISA/MS&cod_menu=1696&cod_modulo=134
2024-04-01
2026-08-30
2026-08-30
2026-08-30
brazil
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Device Classification
Classify device under ANVISA RDC 751/2022 (Class I, II, III, or IV).
2-4 weeks
🏷️
2
Appoint BRH
Foreign manufacturers must appoint a Brazil Registration Holder (BRH) for registration.
4-8 weeks
🏛️
3
GMP Certificate
Obtain ANVISA B-GMP certificate or MDSAP certificate covering Brazil. Facility audit required.
6-12 months
🏭
4
Technical Documentation
Prepare ANVISA-compliant technical dossier. Portuguese translation required.
2-4 months
📋
5
ANVISA Submission
BRH submits registration application to ANVISA via electronic system.
1-2 weeks
📤
6
ANVISA Review
ANVISA conducts technical review. IN 290/2024 offers faster pathway with FDA/EU/TGA approval.
6-18 months
⚙️
7
Registration
ANVISA issues registration. Valid 10 years (or 5 years without MDSAP).
2-4 weeks
✅
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
brazil
Brazil
BR
ANVISA
175.72
3514.32
BRL
Yes
780.96
49641.2
BRL
Yes
notification-class-i-ii
Class I/II notification (fato gerador 752)
BRL
3514.32
175.72
3514.32
BRL 175.72–3,514.32
Per notification
Exact payable amount depends on the ANVISA-recognized company-size group.
exact-current
official-verified
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
ANVISA RDC 857/2024, Annex I TFVS fee matrix
2024-06-03
2026-08-25
registration-medium-small-device
Class III/IV registration — medium/small device (731)
BRL
15619.2
780.96
15619.2
BRL 780.96–15,619.20
Per registration
Single device; range is microenterprise through Group I large enterprise.
exact-current
official-verified
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
ANVISA RDC 857/2024, Annex I TFVS fee matrix
2024-06-03
2026-08-25
registration-medium-small-family
Class III/IV registration — medium/small family (733)
BRL
21274.8
1063.74
21274.8
BRL 1,063.74–21,274.80
Per family registration
Range is microenterprise through Group I large enterprise.
exact-current
official-verified
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
ANVISA RDC 857/2024, Annex I TFVS fee matrix
2024-06-03
2026-08-25
registration-large-device
Class III/IV registration — large equipment (730)
BRL
39048
1952.4
39048
BRL 1,952.40–39,048.00
Per registration
Large diagnostic or therapeutic equipment; range depends on company size.
exact-current
official-verified
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
ANVISA RDC 857/2024, Annex I TFVS fee matrix
2024-06-03
2026-08-25
registration-large-family
Class III/IV registration — large-equipment family (732)
BRL
49641.2
2482.06
49641.2
BRL 2,482.06–49,641.20
Per family registration
Range is microenterprise through Group I large enterprise.
exact-current
official-verified
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
ANVISA RDC 857/2024, Annex I TFVS fee matrix
2024-06-03
2026-08-25
renewal-medium-small-device
Registration renewal — medium/small device (735)
BRL
14057.28
702.86
14057.28
BRL 702.86–14,057.28
Per renewal
The Annex already includes the renewal discount and company-size reductions.
exact-current
official-verified
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
ANVISA RDC 857/2024, Annex I TFVS fee matrix
2024-06-03
2026-08-25
renewal-medium-small-family
Registration renewal — medium/small family (736)
BRL
19147.32
957.37
19147.32
BRL 957.37–19,147.32
Per family renewal
exact-current
official-verified
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
ANVISA RDC 857/2024, Annex I TFVS fee matrix
2024-06-03
2026-08-25
renewal-large-device
Registration renewal — large equipment (734)
BRL
35143.2
1757.16
35143.2
BRL 1,757.16–35,143.20
Per renewal
exact-current
official-verified
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
ANVISA RDC 857/2024, Annex I TFVS fee matrix
2024-06-03
2026-08-25
renewal-large-family
Registration renewal — large-equipment family (737)
BRL
44677.08
2233.85
44677.08
BRL 2,233.85–44,677.08
Per family renewal
exact-current
official-verified
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
ANVISA RDC 857/2024, Annex I TFVS fee matrix
2024-06-03
2026-08-25
post-registration-change
Post-registration change or inclusion (738)
BRL
3514.32
175.72
3514.32
BRL 175.72–3,514.32
Per petition
Labeling/instructions-only changes under fact generator 742 are exempt.
exact-current
official-verified
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
ANVISA RDC 857/2024, Annex I TFVS fee matrix
2024-06-03
2026-08-25
cbpf-brazil-mercosur
GMP certification — Brazil or Mercosur site (726)
BRL
26593.5
1329.68
26593.5
BRL 1,329.68–26,593.50
Per site and production line
Company-size discounts apply.
exact-current
official-verified
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
ANVISA RDC 857/2024, Annex I TFVS fee matrix
2024-06-03
2026-08-25
cbpf-other-country
GMP certification — site outside Mercosur (727)
BRL
72804.9
BRL 72,804.90
Per site and production line
RDC 857/2024 excludes non-Mercosur GMP certification from company-size discounts.
exact-current
official-verified
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
ANVISA RDC 857/2024, Annex I TFVS fee matrix
2024-06-03
2026-08-25
2026-08-25
official-verified
ANVISA RDC 857/2024, Annex I TFVS fee matrix
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
2024-06-03
2026-08-25
2026-08-25
exact-current
Yes
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
brazil
Brazil
high
inmetro-sbac-conformity-certificate
INMETRO/SBAC conformity certificate
Medical Electrical Safety
Mandatory If Feature
Covered Electromedical Or Listed Product
ANVISA Registro FAQ Q5 directs to INMETRO IN 116/2021 and RDC 549/2021 for compulsory certification of certain electromedical equipment (electrical safety).
candidate
anatel-certification-and-homologation
ANATEL certification and homologation
Radio Spectrum
Mandatory If Feature
Radio Or Telecommunications Product
candidate
inmetro-legal-metrology-type-approval-verification
INMETRO legal-metrology type approval/verification
Legal Metrology
Mandatory If Feature
Regulated Measuring Instrument
candidate
ansn-cnen-radiation-import-transfer-use-authorization
ANSN/CNEN radiation import/transfer/use authorization
Ionizing Radiation
Mandatory If Feature
Radiation Equipment Source And Use Site
candidate
anvisa-sbac-product-specific-conformity
ANVISA/SBAC product-specific conformity
Product Specific Conformity
Mandatory If Feature
Listed Product Category
RDC 848/2024 Art. 1 §3: essential safety and performance requirements are verified by the sanitary authority at GMP inspection, registration/notification or surveillance; labelling may use ABNT NBR ISO 15223 symbols (RDC 830/2023 Art. 46 VI).
candidate
ANVISA
medical devices and compulsory conformity
https://www.gov.br/anvisa/en/regulation-of-products/medical-devices
INMETRO
health-surveillance equipment certification
https://www.gov.br/inmetro/pt-br/acesso-a-informacao/perguntas-frequentes/avaliacao-da-conformidade/equipamentos-sob-regime-de-vigilancia-sanitaria/como-certifico-um-produtos-sob-vigilancia-sanitaria
ANATEL
telecommunications product certification
https://www.gov.br/anatel/pt-br/regulado/certificacao-de-produtos
INMETRO
legal metrology instruments
https://www.gov.br/inmetro/pt-br/assuntos/vigilancia-de-mercado/fiscalizaveis/instrumentos-de-medicao
ANSN/CNEN
radiation installation and equipment requests
https://www.gov.br/ansn/pt-br/servicos/instalacoes-radioativas/requerimentos-e-tlc
ANVISA
product registration FAQ INMETRO IN 116/2021 and RDC 549/2021 checklist
https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/produtos-para-saude/registro/registro-de-produtos
